The COVID-19 pandemic required manufacturers and importers of medicinal products and regulatory authorities to operate under business continuity mode, impacting the standard way of working. As a result it was necessary to publish guidance on regulatory expectations and flexibility during the COVID-19 pandemic to minimise risks of shortages while ensuring that the high standards of quality, safety and efficacy of medicines made available to patients in the EU were maintained. This guidance has been developed in cooperation between the European Commission, the Coordination group for Mutual recognition and Decentralised procedures – human (“CMDh”), the Inspectors Working Group, the Coordination group for Mutual recognition and Decentralised procedures – veterinary (“CMDv”) and EMA.
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